Alzheimer's DiseasePhase 1/2NCT04248270
A Noval Tau Tracer in Young Onset Dementia
A Phase 1/2 study testing 18F-PM-PBB3 in people with Alzheimer's Disease and Vascular Dementia, run by Chang Gung Memorial Hospital.
Trial summary
Dementia is a clinical syndrome which characterized by progressive cognitive impairment, behavior disturbance and dysfunction of daily activity. In aging population, Alzheimer's dementia (AD) is the most common late onset dementia which occupied about 50-75%, the vascular dementia, frontotemporal lobardegeneration… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Alzheimer's Disease, Vascular Dementia, Dementia
- What is being tested?
- 18F-PM-PBB3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 30 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Very mild to moderate stage YOD inclusion criteria:
- Age between 20-75 years old.
- YOD is defined by the dementia onset before age 65 years old. The dementia syndrome is based on the NIA-AA criteria of all-cause of dementia . Briefly it required:
- Interfere with the ability to function at work or at usual activities.
- Represent a decline from previous levels of functioning and performing.
- Cognitive impairment is detected and diagnosed through a combination of a). history-taking form the patient and a knowledgeable informant b). an objective cognitive assessment, either a 'bedside' mental status examination or neuropsychological testing.
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- The cognitive or behavioral impairment involves a minimum of two of the below domains: impaired ability to acquire and remember new information, impaired reasoning and handling of complex tasks poor judgment, impaired visuospatial abilities, impaired language functions, changes in personality, behavior or comportment symptoms.
- The severity of dementia is limited from very mild to moderate stage in current project. The definition of very mild to moderate stage of dementia is based on the clinical dementia rating scale (CDR) from 0.5-2 YOD2019 3 Exclusion Criteria
- Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
- Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous severe head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases.
- Major psychiatric disorders, drug or alcohol abuse and major depression
- Pregnant women or breast- feeding women.
- Patients in whom MRI was contraindicated or patient had claustrophobia.
- History of severe allergic or anaphylactic reactions particularly to the tested drugs.
- History of positive test for human immunodeficiency virus (HIV).
- Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values).
Who cannot join
None listed.
About this study
Official title: A Noval Tau Tracer ([18F]PM-PBB3) in Young Onset Dementia: Clinical and Neuroimaging Study
Dementia is a clinical syndrome which characterized by progressive cognitive impairment, behavior disturbance and dysfunction of daily activity. In aging population, Alzheimer's dementia (AD) is the most common late onset dementia which occupied about 50-75%, the vascular dementia, frontotemporal lobardegeneration (FTLD) and corticobasal syndrome is followed. On the other hand, the young onset dementia (YOD), which represents the onset of dementia before65 years old, is only about 1/10 to 1/100 proportion of late onset dementia. The YOD is different from late onset dementia in the proportion of degenerative subtype (e.g. the FTLD is more frequent than AD). Besides, frequent atypical presentation of clinical syndrome in the YOD which characterize the different variant of AD made the early accurate diagnosis of AD is more difficult. Currently, there is no available data to describe the proportion of subtype in YOD in Taiwan. In AD dementia, two important biomarkers are amylod plaque made by ß-amyloid protein and neurofibrillary tangle made by phosphorylation tau protein. In the past, they only can be seen under the microscope findings at autopsy study. Recently, the new amyloid tracer and tau tracer had been developed and could evaluate the deposition of amyloid and tau protein in human brain. These progresses had substantially improved the accurate diagnosis of degenerative dementia. A noval tau tracer [ 18F]PM-PBB3, which had substantially improved the off-target binding and more clear background in human brain than previous tau tracer. In current project, investigator will aim to consecutive collect 50 YOD due to the neurodegeneration in 3 years using the NIA-AA research framework system(ATN system) to achieve accurate diagnosis of the dementia subtype by the detail clinical neurology study, neuropsychological examination, amyloid positron emission tomography (PET) and tau PET study. In the first year, investigator will perform feasibility study to explore the topographical tau distribution in different subtype of YOD. In the next 2 years, investigator will perform a large scale study in a group of YOD to understand the amyloid and tau deposition and their association with clinical parameters. From current project, investigator could understand the tau deposition in different YOD subtype. Investigator also could understand the correlation between clinical phenotype and molecular pathology. Investigator will use a mathematic model to construct the model of diffusion kurtosis imaging from brain magnetic resonance imaging (MRI) and relate the white matter integrity with amyloid and tau PET imaging.
- Conditions
- Alzheimer's Disease, Vascular Dementia, Dementia
- Being tested
- 18F-PM-PBB3
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PM-PBB3Drug
All scans will be acquired in pairs of 18F-florbetapir(18F-AV45) and/or18F-PM-PBB3 PET scans (if patient select), performed on separate days, and at least 2 days apart, with either scan performed first. The 18F-florbetapir and 18F-PM-PBB3 protocol will entail the inon of 5±2mCi of tracer followed by an uptake phase of 50 min during which time the state of the subject is not important. After 40 minutes, subjects will be positioned and 4 x 5 min frames of emission data will be collected right at 50 min after tracer injection. PET/MRI scans will precede this acquisition with a MRI scan for attenuation correction; PET-only scanners will perform a transmission scan following the emission scan.
| Study group | Role | What they receive |
|---|---|---|
| The relationship between image and AD disease | Other | To evaluate the relationship between F-18-PMPBB3 PET image uptake pattern and AD disease classifications. Receives: Drug: 18F-PM-PBB3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
understand the proportion of subtype in YOD
investigator would be able to understand the proportion of subtype in YOD
Measured: 3 years
understand the mean tau deposition in different region of interest from subtype of YOD
investigator will perform image analysis to understand tau deposition in different subtype of YOD based on 18F-PM-PBB3 tau tracer image. The mean intensity from selected region of interest will be recorded for different group comparison.
Measured: 3 years
understand the mean tau intensity in different region of interest and find correlation with cognition
investigator will perform association study to explore clinical measurements such as cognition and demographic data associate with tau intensity from different region of interest
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start20 Feb 2020 (estimated)
- Primary completion17 Aug 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsu, Jung-Lung, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248270
- Sponsor's protocol ID
- 201802151A0
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Noval Tau Tracer ([18F]PM-PBB3) in Young Onset Dementia: Clinical and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT04248270
- Acronym / sponsor ID
- 201802151A0
- Conditions
- Alzheimer's Disease, Vascular Dementia, Dementia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 17 Aug 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia is a clinical syndrome which characterized by progressive cognitive impairment, behavior disturbance and dysfunction of daily activity. In aging population, Alzheimer's dementia (AD) is the most common late onset dementia which occupied about 50-75%, the vascular dementia, frontotemporal lobardegeneration (FTLD) and corticobasal syndrome is followed. On the other hand, the young onset dementia (YOD), which represents the onset of dementia before65 years old, is only about 1/10 to 1/100 proportion of late onset dementia. The YOD is different from late onset dementia in the proportion of degenerative subtype (e.g. the FTLD is more frequent than AD). Besides, frequent atypical presentation of clinical syndrome in the YOD which characterize the different variant of AD made the early accurate diagnosis of AD is more difficult. Currently, there is no available data to describe the proportion of subtype in YOD in Taiwan. In AD dementia, two important biomarkers are amylod plaque made by ß-amyloid protein and neurofibrillary tangle made by phosphorylation tau protein. In the past, they only can be seen under the microscope findings at autopsy study. Recently, the new amyloid tracer and tau tracer had been developed and could evaluate the deposition of amyloid and tau protein in human brain. These progresses had substantially improved the accurate diagnosis of degenerative dementia. A noval tau tracer [ 18F]PM-PBB3, which had substantially improved the off-target binding and more clear background in human brain than previous tau tracer. In current project, investigator will aim to consecutive collect 50 YOD due to the neurodegeneration in 3 years using the NIA-AA research framework system(ATN system) to achieve accurate diagnosis of the dementia subtype by the detail clinical neurology study, neuropsychological examination, amyloid positron emission tomography (PET) and tau PET study. In the first year, investigator will perform feasibility study to explore the topographical tau distribution in different subtype of YOD. In the next 2 years, investigator will perform a large scale study in a group of YOD to understand the amyloid and tau deposition and their association with clinical parameters. From current project, investigator could understand the tau deposition in different YOD subtype. Investigator also could understand the correlation between clinical phenotype and molecular pathology. Investigator will use a mathematic model to construct the model of diffusion kurtosis imaging from brain magnetic resonance imaging (MRI) and relate the white matter integrity with amyloid and tau PET imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The relationship between image and AD disease | Other | Drug: 18F-PM-PBB3To evaluate the relationship between F-18-PMPBB3 PET image uptake pattern and AD disease classifications. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 20-75 years old.
- YOD is defined by the dementia onset before age 65 years old. The dementia syndrome is based on the NIA-AA criteria of all-cause of dementia . Briefly it required:
- Interfere with the ability to function at work or at usual activities.
- Represent a decline from previous levels of functioning and performing.
- Cognitive impairment is detected and diagnosed through a combination of a). history-taking form the patient and a knowledgeable informant b). an objective cognitive assessment, either a 'bedside' mental status examination or neuropsychological testing.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PM-PBB3All scans will be acquired in pairs of 18F-florbetapir(18F-AV45) and/or18F-PM-PBB3 PET scans (if patient select), performed on separate days, and at least 2 days apart, with either scan performed first. The 18F-florbetapir and 18F-PM-PBB3 protocol will entail the inon of 5±2mCi of tracer followed by an uptake phase of 50 min during which time the state of the subject is not important. After 40 minutes, subjects will be positioned and 4 x 5 min frames of emission data will be collected right at 50 min after tracer injection. PET/MRI scans will precede this acquisition with a MRI scan for attenuation correction; PET-only scanners will perform a transmission scan following the emission scan. | Drug | The relationship between image and AD disease |
Primary outcome
understand the proportion of subtype in YOD
Time frame: 3 years
investigator would be able to understand the proportion of subtype in YOD
understand the mean tau deposition in different region of interest from subtype of YOD
Time frame: 3 years
investigator will perform image analysis to understand tau deposition in different subtype of YOD based on 18F-PM-PBB3 tau tracer image. The mean intensity from selected region of interest will be recorded for different group comparison.
understand the mean tau intensity in different region of interest and find correlation with cognition
Time frame: 3 years
investigator will perform association study to explore clinical measurements such as cognition and demographic data associate with tau intensity from different region of interest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 18F-PM-PBB3 in people with Alzheimer's Disease and Vascular Dementia, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
understand the proportion of subtype in YOD (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.